Trial document
DRKS00013614
Trial Description
Title
cENZIAN versus ENZIAN – An observational multicenter study on
the prediction of a preoperative to an intraoperative ENZIAN classification for
endometriosis surgery.
Trial Acronym
cENZIAN-Trial
URL of the Trial
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Brief Summary in Lay Language
This study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The planned number of participants is 900-1000 patients. The study is a pure observational study without risk for the study participants.
Brief Summary in Scientific Language
This multicenter study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis. This study is important because in recent years, the importance of preoperative diagnostics in deep infiltrating endometriosis has increased significantly. The study is to be classified as a non-interventional method study (classification of the cENZIAN classification as a new diagnostic method without any risk for the study participants). The planned number of participants is 900-1000 patients.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00013614
- 2017/12/22
- [---]*
- yes
- Approved
- 1002/2017, Ethikkommission des Landes Oberösterreich
Secondary IDs
- [---]*
Health Condition or Problem studied
- N80 - Endometriosis
Interventions/Observational Groups
- In patients with a planned endometriosis surgery, the common diagnostic measures are carried out routinely (depending on the use or need: palpation/speculum, ultrasound, MRI or further imaging), regardless of the study. The responsible physician will then fill out the section "cENZIAN" in the questionnaire for each diagnostic measure. At the end of the surgical procedure, the surgeon records his intraoperative impressions under the heading "ENZIAN". This concludes the study participation of the patient.
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Diagnostic
- Single (group)
- N/A
- N/A
Primary Outcome
This study should serve as a review whether the results of a postoperative
performed disease classification ("ENZIAN" classification) are predictable by the preoperative application of this classification ("cENZIAN") in patients with endometriosis.
Secondary Outcome
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Countries of Recruitment
- Austria
- Germany
- Czech Republic
- Switzerland
Locations of Recruitment
- University Medical Center
- University Medical Center
- University Medical Center
- Medical Center
- Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- Medical Center
- Medical Center
Recruitment
- Actual
- 2018/01/16
- 900
- Multicenter trial
- International
Inclusion Criteria
- Female
- 18 Years
- no maximum age
Additional Inclusion Criteria
• Informed consent to participate in the study after preceding written and verbal information
• Suspected or confirmed endometriosis with planned surgery within 6 months
• Ability to consent
• Age > 18 years
Exclusion Criteria
Inapplicability of the diagnostic procedures routinely provided for preoperative endometriosis-specific knowledge acquisition (e.g. gynecological examination, ultrasound or other imaging)
Addresses
-
start of 1:1-Block address primary-sponsor
- Kepler Universitätsklinikum
- 4020 Linz
- Austria
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- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
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- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
- Mr. Dr. Simon-Hermann Enzelsberger
- Krankenhausstraße 26-30
- 4020 Linz
- Austria
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +43 5 7680 84 23718
- [---]*
- simon-hermann.enzelsberger at kepleruniklinikum.at
- https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie
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- Kepler Universitätsklinikum - Universitätsklinik für Gynäkologie, Geburtshilfe und Gyn. Endokrinologie
- Mr. Dr. Simon-Hermann Enzelsberger
- Krankenhausstraße 26-30
- 4020 Linz
- Austria
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +43 5 7680 84 23718
- [---]*
- simon-hermann.enzelsberger at kepleruniklinikum.at
- https://www.kepleruniklinikum.at/versorgung/kliniken/gynaekologie-geburtshilfe-und-gyn-endokrinologie
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Kepler Universitätsklinikum
- 4020 Linz
- Austria
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end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- [---]*
- [---]*
- 2019/11/27
- 673
- 1144